The TMF is the official record of the clinical study for Regulatory Authorities, be it…
It’s no surprise that an underperforming site can cause significant delays in meeting important accrual targets, data timelines, or study objectives. Conducting successful clinical trials and propelling the development of novel therapeutics forward cannot be done without the compliance of clinical research sites. As such, in their role of carrying out the protocol and as the first-line contact with patients, site personnel have a direct impact on the success or failure of a trial.
Underperforming sites are typically thought of as sites with insufficient enrolment performance. However, in a pre-emptive scenario under a more proactive approach this term can also refer to sites that present with a range of issues such as: difficult communication; engagement challenges; failure to address issues in a timely manner; or poor data quality.
Any one of these issues could lead to data integrity issues or human subject protection concerns, causing a potential pitfall for the study overall if left unaddressed. Given this preeminent level of impact, rest assured that with the right approach, appropriate guidance and actions, underperforming sites can be turned around in a timely manner to successfully contribute to the betterment of the overall study.
From the Start – Choose the Right Sites!
Ensuring your sites have the best chance of success starts at the very outset of your study with site selection. From the first point of contact through to site activation, it’s important that expectations are clearly defined so an accurate understanding of the site’s personnel, resources, interest, expertise, and access to the patient population can be assessed. Having frank discussions with sites during this process allows both site staff and the CRA to determine if the protocol truly is a good fit. This reduces the potential for future disappointment and saves valuable time and money lost that can result from initially selecting inappropriate sites for your study.
At Scimega, site-selection is performed using our Scimega Reserve Feasibility™ program designed to quickly match the specific scientific interests and patient needs of leading Canadian investigative sites with study protocol and design objectives. We have well established relationships with cancer centres across Canada and can quickly identify the top enrollers in their respective fields. From the outset, through our combined methodology and experience Scimega readily identifies suitable sites that will best serve your study based on previous performance, current interests and expertise.
Ask the Right Questions
To troubleshoot a site’s underperformance the first step is to not only identify the problem but to determine the underlying reason why it occurred. Critical to the process of undertaking an effective root cause analysis is knowing the right questions to ask. For example, if a site is underperforming due to low enrolment it’s not enough to simply instruct the site to enroll more patients. To be effective the CRA must investigate the cause through collaborative inquiry as to the possible reasons for low enrolment: are the eligibility criteria too restrictive, and if so, which one(s) and why? Are there any new competing trials? Has standard of care changed? Scimega CRAs are trained to uncover the “why” and tease out the root cause of a problem in a collaborative context with site personnel. This makes Scimega CRAs better equipped to provide sites with the support needed to get back on track, whether it be recruitment plan suggestions, streamlining communication, or providing additional assistance with query resolution.
Asking the right questions in a cooperative manner to uncover meaningful responses that expose the root cause of the problem(s) that led to underperformance is key. Effective listening and appropriate action in response is the path to turning things around in a timely manner.
Engage the Site Team
Investigative site teams are a treasure trove of great ideas and feedback. Once an issue is identified and the root cause is determined, asking for feedback from site personnel in different roles is extremely valuable and may even lead to changes for the betterment of the study overall.
Respecting the site’s feedback and escalating to sponsor personnel when appropriate empowers site staff and promotes ownership over the trial. It also serves to build trust between the site team and CRA. This supportive approach to relationships with site staff provides a level of comfort and trust to discuss issues no matter how big or small. In turn this allows the CRA to move quickly to resolution. Affording an opportunity to increase the site’s confidence in the trial and further bolster the CRA and site study team relationship.
Discussions around underperformance should never point blame. Instead focus the discussion on future improvements to maintain and potentially enhance productive working relationships with sites, sponsor, and ultimately the patients served.
No One Size Fits All
Every site operates differently. A similar issue at two different sites must often be approached and resolved differently based on site staff and how they may function at either site.
Knowing who to contact and tailoring communication allows the CRA to cater their approach to ensure quick resolution with minimal conflict, and without over-burdening site staff unnecessarily.
The CRA who understand site-specific policies and procedures is best positioned to not only identify a problem when it occurs, but to suggest solutions that work within the specific constrains of a particular site’s policies.
Choosing the Right Partner
To transform an underperforming site into a productive and engaged one is possible under the right guidance. Enlisting the help of a monitoring CRO with a motivated CRA team of experts in their field, and experienced in site management can contribute to your trial success.
The Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies. Scimega selected and motivated Canadian sites achieved an FPI surpassing its own 6-week KPI target in 2021, and over 90% of active sites enrolled participants.
To a great extent, the future success of an increasingly more complex clinical trials industry to bring new products to market rests on the ability of sponsors and CROs with their network of sties to work together ever more effectively. Whereby all parties benefit from strong partnership established on a meeting of goals and ‘minds’ to forge win-win-win outcomes for the sponsor, the CRO, and the sites and patients served.
Contributed by: Sarah Young, CCRP, Senior Clinical Research Associate